ActivaPin™ B-AP-2730

GUDID E302BAP27309

ActivaPin™ 2.7 mm x 30 mm

Bioretec Oy

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Primary Device ID	E302BAP27309
NIH Device Record Key	6f121356-ee05-475a-8bd4-16ec3e23ccaa
Commercial Distribution Status	In Commercial Distribution
Brand Name	ActivaPin™
Version Model Number	B-AP-2730
Catalog Number	B-AP-2730
Company DUNS	368715301
Company Name	Bioretec Oy
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com
Phone	+358207789500
Email	sales@bioretec.com

Device Dimensions

Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter
Length	30 Millimeter
Width	2.7 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E302BAP27309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K080879

FDA Product Code

HTY	Pin, Fixation, Smooth

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-08-25

On-Brand Devices [ActivaPin™]

E302BAP32709	ActivaPin™ 3.2 mm x 70 mm
E302BAP32609	ActivaPin™ 3.2 mm x 60 mm
E302BAP32509	ActivaPin™ 3.2 mm x 50 mm
E302BAP32409	ActivaPin™ 3.2 mm x 40 mm
E302BAP27709	ActivaPin™ 2.7 mm x 70 mm
E302BAP27609	ActivaPin™ 2.7 mm x 60 mm
E302BAP27509	ActivaPin™ 2.7 mm x 50 mm
E302BAP27409	ActivaPin™ 2.7 mm x 40 mm
E302BAP27309	ActivaPin™ 2.7 mm x 30 mm
E302BAP20709	ActivaPin™ 2.0 mm x 70 mm
E302BAP20609	ActivaPin™ 2.0 mm x 60 mm
E302BAP20509	ActivaPin™ 2.0 mm x 50 mm
E302BAP20409	ActivaPin™ 2.0 mm x 40 mm
E302BAP20309	ActivaPin™ 2.0 mm x 30 mm
E302BAP20209	ActivaPin™ 2.0 mm x 20 mm
E302BAP15709	ActivaPin™ 1.5 mm x 70 mm
E302BAP15609	ActivaPin™ 1.5 mm x 60 mm
E302BAP15509	ActivaPin™ 1.5 mm x 50 mm
E302BAP15409	ActivaPin™ 1.5 mm x 40 mm
E302BAP15309	ActivaPin™ 1.5 mm x 30 mm
E302BAP15209	ActivaPin™ 1.5 mm x 20 mm